Signal FDA removes the testosterone cardiovascular black box warning in February 2025

Summary

The Men's Wellbeing Initiative marks February 2025 as a turning point in testosterone regulation. The TRAVERSE trial of 2023, which enrolled 5,246 men and is the largest randomized trial of testosterone therapy yet, found the treatment cardiovascularly safe in monitored men with hypogonadism. Following that evidence, the US Food and Drug Administration removed the black box warning on cardiovascular risk from all testosterone products. The Initiative calls this a pivotal regulatory moment for men's hormonal health. At the same time it reports that prescriptions are growing, especially among men aged 35 to 44, partly because telehealth companies have entered hormone therapy. It cautions that treating testosterone as an optimization product blurs the line between medicine and lifestyle.